Lilly to Present CYRAMZA® (ramucirumab) Data at 2015 ASCO Annual Meeting

INDIANAPOLIS, May 28, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced that data from several trials of CYRAMZA® (ramucirumab) will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, including a Phase II study of non-small cell lung cancer (NSCLC) patients in Japan. Other data, including those from global Phase III studies of CYRAMZA in gastric, non-small cell lung, and hepatocellular cancers, will also be presented at the meeting.   

"In just over a year, CYRAMZA received four full FDA approvals in advanced or metastatic forms of three of the world's most common and deadly cancers - gastric, non-small cell lung, and colorectal. We believe this is a first for an oncology product, and our CYRAMZA ASCO disclosures supplement these clinical advances," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "Further data at the meeting show how we are investigating CYRAMZA in other difficult-to-treat cancers, such as hepatocellular carcinoma, to help address additional unmet needs for people battling this devastating disease."

Selected highlights:

Abstract #8054
A Phase II, double-blind, multicenter trial in Japan of patients with advanced NSCLC who were treated in the second-line setting with either ramucirumab and docetaxel or placebo and docetaxel found that the ramucirumab arm had results consistent with those from the global Phase III REVEL trial, which supported the third U.S. approval for ramucirumab in 2014.

The Phase II trial examined 157 patients from Japan with stage IV NSCLC following disease progression during or after prior platinum-based chemotherapy. Patients treated on the ramucirumab-plus-docetaxel arm (n=76) achieved a median progression-free survival (PFS), the study's primary endpoint, of 5.22 months, compared to 4.21 months on the placebo-plus-docetaxel arm (n=81) (HR 0.83; 95% CI: 0.59-1.16). Among secondary endpoints, patients on the ramucirumab-plus-docetaxel arm achieved a median overall survival (OS) of 15.15 months as compared to 13.93 months on the placebo-plus-docetaxel arm (HR 0.77; 95% CI: 0.48-1.24), and an objective response rate (ORR) of 28.9 percent on the ramucirumab-plus-docetaxel arm as compared to 18.5 percent on the placebo-plus-docetaxel arm. The most common ( > 5% incidence) grade 3/4 adverse events occurring more frequently in patients on the ramucirumab arm were febrile neutropenia (34.2% vs. 19.8%), decreased appetite (10.5% vs. 6.2%), hypertension (5.3% vs. 0%), and stomatitis (5.3% vs. 0%).

Based on the results of this Phase II study, Lilly plans a submission to regulatory authorities in Japan this year.

Abstract #4028
Twelve prognostic factors were identified to help build a prognostic model for second-line gastric cancer patients, using data from the largest randomized, controlled global trial dataset (n=1,020) in this setting, which is composed of REGARD and RAINBOW - two global Phase III trials that supported the first two U.S. approvals for ramucirumab in 2014.

The REGARD trial studied ramucirumab (plus best supportive care) as a single agent for patients with locally advanced or metastatic gastric cancer including gastroesophageal junction (GEJ) adenocarcinoma who were previously treated with fluoropyrimidine- or platinum-containing chemotherapy. RAINBOW studied ramucirumab in combination with paclitaxel in the same patient setting.

In this prognostic factor analysis, individual patient data from both trials were pooled and 41 key baseline covariates (19 clinical characteristics and 22 laboratory parameters) common to both studies were examined. Of the 1,020 patients, 953 (93%) were included in a stepwise Cox regression that identified the following 12 independent prognostic factors: peritoneal metastasis; time to progressive disease on prior therapy of less than six months; ECOG performance score ≥1; poor or unknown tumor differentiation; primary tumor present; high alkaline phosphatase; low sodium; high lactate dehydrogenase; high aspartate aminotransferase; low albumin; low lymphocytes; and high neutrophils.

From these results, investigators have developed a simple prognostic index that will divide patients into risk groups, which may help support clinical decision-making, patient risk stratification, and future clinical study planning.

Overall, ramucirumab is featured in more than a dozen presentations at this year's ASCO Annual Meeting. A Trials-in-Progress (TPS #4131) poster focuses on a new Phase III first-line metastatic gastric or GEJ adenocarcinoma study called RAINFALL, which is evaluating ramucirumab in combination with capecitabine and cisplatin (ClinicalTrials.gov identifier: NCT02314117).  

About CYRAMZA® (ramucirumab)
In the U.S., CYRAMZA (ramucirumab) is approved for use as a single agent or in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in combination with docetaxel (a type of chemotherapy) as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy. Additionally, it is approved with FOLFIRI (a type of chemotherapy) as a treatment for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

There are several additional studies underway or planned to investigate CYRAMZA as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumor types.  

CYRAMZA is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. CYRAMZA inhibited angiogenesis in an in vivo animal model.

About Angiogenesis and VEGF
Angiogenesis is the process of making new blood vessels. In a person with cancer, angiogenesis creates new blood vessels that give a tumor its own blood supply, allowing it to grow and spread.

Some tumors create proteins called VEGF. These proteins attach to the VEGF receptors of blood vessel cells, causing new blood vessels to form around the tumors and enabling growth. Blocking the VEGF protein from linking to the blood vessels helps to inhibit tumor growth by slowing angiogenesis and the blood supply that feeds tumors. Of the three known VEGF receptors, VEGF Receptor 2 is linked most closely to VEGF-induced tumor angiogenesis.

INDICATIONS
Gastric Cancer
CYRAMZA, as a single agent or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Non-Small Cell Lung Cancer
CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.

Colorectal Cancer
CYRAMZA, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

IMPORTANT SAFETY INFORMATION FOR CYRAMZA

WARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, AND IMPAIRED WOUND HEALING


Hemorrhage: CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue CYRAMZA in patients who experience severe bleeding.


Gastrointestinal Perforation: CYRAMZA can increase the risk of gastrointestinal perforation, a potentially fatal event. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.


Impaired Wound Healing: Impaired wound healing can occur with antibodies inhibiting the VEGF pathway. Discontinue CYRAMZA therapy in patients with impaired wound healing. Withhold CYRAMZA prior to surgery and discontinue CYRAMZA if a patient develops wound healing complications.

Warnings and Precautions

Hemorrhage

Arterial Thromboembolic Events (ATEs)

Hypertension

Infusion-Related Reactions (IRRs)

Gastrointestinal Perforations

Impaired Wound Healing

Clinical Deterioration in Child-Pugh B or C Cirrhosis

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

Proteinuria Including Nephrotic Syndrome

Thyroid Dysfunction

Embryofetal Toxicity

Most Common Adverse Reactions—Single Agent

Most Common Adverse Reactions—Combination With Paclitaxel

Most Common Adverse Reactions—Combination With Docetaxel

Most Common Adverse Reactions—Combination With FOLFIRI

Drug Interactions

Use in Specific Populations

Please see full Prescribing Information for CYRAMZA, including Boxed Warnings for hemorrhage, gastrointestinal perforation, and impaired wound healing.
RB-P HCP ISI 24APR2015

About Lilly Oncology
For more than fifty years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com  and newsroom.lilly.com/social-channels. (P-LLY)

© Lilly USA, LLC 2015. ALL RIGHTS RESERVED.
CYRAMZA is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

Lilly Forward-Looking Statement
This press release contains "forward-looking statements" (as that term is defined in the United States Private Securities Litigation Reform Act of 1995) regarding CYRAMZA® (ramucirumab) as a potential treatment for non-small cell lung cancer, gastric cancer, hepatocellular carcinoma, or other diseases. This press release reflects Lilly's current beliefs. However, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other risks, there can be no guarantee that this medicine will receive regulatory approval in this setting, or, if approved, that it will achieve intended benefits or become a commercially successful product. For further discussion of these and other risks and uncertainties that could cause actual results to differ materially from Lilly's expectations, please see the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements.

 

Refer to:

Tracy Henrikson; tracy.henrikson@lilly.com; 609-240-3902 (Lilly)


Neil Hochman; n.hochman@togorun.com; 212-453-2067 (TogoRun)

 

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